Cleared Traditional

Gems Vitrification Set, Gems Warming Set

K162409 · Genea Biomedx Pty, Ltd. · Obstetrics & Gynecology
May 2017
Decision
268d
Days
Class 2
Risk

About This 510(k) Submission

K162409 is an FDA 510(k) clearance for the Gems Vitrification Set, Gems Warming Set, a Media, Reproductive (Class II — Special Controls, product code MQL), submitted by Genea Biomedx Pty, Ltd. (Sydney, AU). The FDA issued a Cleared decision on May 24, 2017, 268 days after receiving the submission on August 29, 2016. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.6180.

Submission Details

510(k) Number K162409 FDA.gov
FDA Decision Cleared SESE
Date Received August 29, 2016
Decision Date May 24, 2017
Days to Decision 268 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF

Device Classification

Product Code MQL — Media, Reproductive
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.6180

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